Title of Study: IRB# 09-0939: Sweet Preference and Alcohol Craving Predict Naltrexone Response in Alcoholism

Purpose:

The proposed 2-year investigation will be the first double-blind, placebo-controlled trial examining the hedonic response to sweet taste (HRST) as a phenotypic predictor of naltrexone (NTX) response in alcohol dependence. HRST yields two primary phenotypes-Sweet Likers (SL) and Sweet Dislikers (SDL). Based on preliminary findings, HRST will be examined in conjunction with craving for alcohol to assess whether the two factors together provide a more robust predictor of NTX response. The identification of methods to predict naltrexone response in alcohol dependence is an important goal for alcohol treatment research. Currently naltrexone is not being used nearly as much as it should be, in part because clinicians do not believe it is very effective. The development of tools that would identify which patients are more likely to have a robust response to naltrexone should lead to increased use of the medication. This could help many patients who are not now having the opportunity of trying naltrexone.

Specific Aims:

There are two principal Specific Aims for the study:

• Specific Aim 1. To test the hypothesis that a combination of SL/SDL status and initial alcohol craving will predict % abstinent days (%ABST) during treatment with naltrexone.
• Specific Aim 2. To test whether a combination of SL/SDL status and initial alcohol craving predict % heavy drinking days (%HDD) during treatment with naltrexone.

Procedures (methods):

Subjects who meet general inclusion/exclusion criteria based on the screening interview will complete a sweet taste assessment. Results, along with craving score, will be given to the Investigational Drug Services for randomization purposes. The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 50 mg oral naltrexone or matching placebo for a 12-week period. In addition participants will meet with a trained therapist for nine 30-minute BRENDA therapy sessions Medical monitoring will also be conducted by study physicians and will consist of review of vital signs, concomitant medication use, and general inquiries into side effects. 

The purpose of this research study is to determine if the pleasurable response to sweets and craving for alcohol can be used to predict response to the medication naltrexone. Naltrexone is an FDA approved medication for treatment of alcohol dependence. In some individuals naltrexone appears to reduce their alcohol consumption and craving while in others it does not.

Based on preliminary information, we believe that how an individual perceives sweet tastes combined with how strong a craving an individual has for alcohol can be used to predict naltrexone response. The study will use a placebo, "sugar pill", to control for non-medication response.